NCT04258852

Brief Summary

The goal of this proposal is to test the overall hypothesis that e-cigarettes (ECs) provide efficient nicotine delivery to the brain and arterial blood in non-EC-naïve smokers and e-cigarette users and that EC liquid characteristics modulate this effect. This study will test the hypothesis through complementary methods that include \[ \[18F\]NCFHEB (aka \[18F\]Flubatine) PET neuroimaging, arterial blood nicotine measurements, and subjective drug effects assessments.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2.9 years until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

February 4, 2020

Last Update Submit

February 13, 2024

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (1)

  • Brain beta-2 nicotinic acetylcholine receptor occupancy

    PET Scan will be utilized to determine the brain beta-2 nicotinic acetylcholine receptor occupancy

    210 minutes

Secondary Outcomes (1)

  • Maximum arterial blood nicotine

    90 minutes

Study Arms (2)

Low Strength, High Strength

EXPERIMENTAL
Drug: Low strength nicotine e-liquidDrug: High strength nicotine e-liquid

High Strength, Low Strength

EXPERIMENTAL
Drug: Low strength nicotine e-liquidDrug: High strength nicotine e-liquid

Interventions

Low strength nicotine e-liquidDRUG

Low strength nicotine e-liquid

High Strength, Low StrengthLow Strength, High Strength
High strength nicotine e-liquidDRUG

High strength nicotine e-liquid

High Strength, Low StrengthLow Strength, High Strength

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women, aged 21-55 years
  • Able to read and write English
  • Able to give voluntary, written informed consent
  • Current cigarette smoking or e-cigarette use
  • Non-treatment seeking
  • Exhaled CO \> 10 ppm or urine cotinine \> 50 ng/ml
  • Agreement to only use e-cigarette products provided in the study
  • Not naïve to vaping (3 or more months and 12 or more times).

You may not qualify if:

  • Current medical condition such as neurological, pulmonary, cardiovascular, endocrine, renal, liver, or thyroid pathology
  • History of or current neurological or psychiatric disorder including drug or alcohol dependence (as per SCID for DSM-5) except Nicotine Dependence
  • Regular or current use of any prescription, herbal or illegal psychotropic medications in the past 1 year, with no current illegal drug use confirmed by urine toxicology (including cannabis)
  • Drink more than 14 drinks per week for women or 21 drinks per week for men;
  • Women who are pregnant or nursing
  • Individuals who are currently taking medication that may affect cholinergic system or nicotine replacement therapy prescribed for smoking cessation;
  • Contraindications to MRI such as claustrophobia or metal in their body, or to PET such as history of cancer Patient unlikely to be able to complete the study as determined by the PI or research assistants
  • Blood donation within eight weeks of the start of the study
  • History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
  • Known hypersensitivity to propylene glycol
  • Planning to quit smoking with a set goal or time for quit attempt
  • Untreated, unresolved acute pulmonary conditions (recurring bronchitis and Reactive airway disorder, as examples).
  • Chronic symptoms on Health Questionnaire that would interfere with monitoring of vaping complication
  • Naïve to vaping (vaping for less than 3 months and less than 12 times)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

December 30, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2025

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)